MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PTH; RADIOIMMUNOASSAY, PARATHYROID HORMONE

Catalog Number	07251068190
Medical Device Problem Codes	Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys pth on two cobas e 801 analytical unit analyzers.The sample initially resulted in a pth value of 65.3 pg/ml when tested on the first e 801 analyzer.The doctor questioned the result, so the sample was repeated.When repeated on a second e 801 analyzer, the result was 84.9 pg/ml.When repeated on a third e 801 analyzer, the result was 61.0 pg/ml.The customer deemed the pth value of 84.9 pg/ml to be correct.
Additional Manufacturer Narrative
The serial number of the first e 801 analyzer is (b)(6).The serial number of the second e 801 analyzer is (b)(6).The serial number of the third e 801 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The customer loaded fresh reagent packs and calibrated them.Precision studies and correlation studies were performed; both had good results.No further issues were reported by the customer.The customer clarified that the assay had not been calibrated since july 2025, so they loaded new reagent packs to get a new lot calibration.Per product labeling, the assay calibration recommendation is every 12 weeks with the same lot and every 28 days when using the same reagent pack.The investigation determined the customer's action resolved the issue.

• Brand Name: ELECSYS PTH
• Common Device Name: RADIOIMMUNOASSAY, PARATHYROID HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23294953
• Report Number: 1823260-2025-04195
• Device Sequence Number: 15932027
• Product Code: CEW
• UDI-Device Identifier: 04015630939787
• UDI-Public: 04015630939787
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K070709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07251068190
• Device Lot Number: 801714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown